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Position Summary:

The Software & Validation Quality Engineer 1 is part of the Quality Assurance team in Quality Department. This role will provide quality assurance support on system validation, software verification, test method validation and process validation to Illumina’s manufacturing operations and global information systems teams, and to ensure that project and sustaining teams follow the defined system/software lifecycle process and conformance to FDA regulations and ISO standards. As an engineer of the Validation & Software Quality Assurance team, this role will be supporting the implementation of continuous improvement to the system/software validation quality process and monitor the health of implemented system/software. As a key member of the Quality department, the individual in this role will be responsible for ensuring compliance to Illumina quality policies and procedures.

Note: This is not a software testing position.

Position Responsibilities:

Provide quality support to new and sustaining verification/validation activities focusing on System, Software, Test Method, MES modeling, Process and/or Facilities & Utilities in Manufacturing area of in charge.
Provide quality support to Development, Lifecycle Management and Manufacturing functions for verification & validation planning and transfer activities. Assist teams in determining verification and validation needs and requirements.
Provide quality support for automated system/software development projects in the manufacturing areas by reviewing and approval of system/software deliverables, in accordance to Illumina Procedures and Work Instructions.
Provide quality assurance support to validation related NCR and CAPAs.
Participate in the development and implementation of validation quality initiatives to address process and system inadequacies to achieve continual quality improvement objectives.
Support in the review and approval of Manufacturing system/software/process and/or facilities related change requests.

Support in the transfer of system/software/process from development into manufacturing product support.
Ensure compliance of validation efforts performed by internal/external validation personnel.
Ensure validation quality activities are in alignment with company goals, objectives and in compliance with Quality Systems.
Participates and provides support in customer, regulatory, internal and corporate audits.
Responsible for escalating potential risks to Management.
Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices.
Provide support in the implementation plans for adherence to new regulatory requirements or expectations.
Perform other duties as may be assigned by Management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

Bachelor’s degree; or equivalent experience in Computer Science, Software Engineering, Informatics, Biological/Life Sciences.
0-2 years of Validation Quality and Software Quality Engineering or relevant experience in a regulated environment, in vitro diagnostics/medical device.
Basic understanding of the applicable regulations and standards: 21CFR 820, 21CFR Part 11, ISO 13485, IEC62304, ISO14971, GAMP5.
Basic knowledge of System/Software Development Lifecycle Models, Software Verification & Validation, Software Configuration Management (SCM), Process Validation, Test Method Validation, Facilities Validation and Risk Management Process.
Basic knowledge on statistics, sampling plans, and statistical analysis.
Experience with Microsoft Office, including Word, Excel and PowerPoint.
Excellent attention to detail, strong organization skills, and ability to work independently and in teams.
Excellent interpersonal skills.
Excellent communication skills, critical thinking and problem-solving abilities.
Ability to operate flexibly in fast-paced environment.
Ability to deliver quality outputs under minimal supervision and guidance.
Ability to influence decision at critical points in time during system/software development lifecycle.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.